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Data / Medical devices / Cradle, Patient, Radiologic

Cradle, Patient, Radiologic (KXH): 19 FDA-registered makers in 7 countries

19 establishments in 7 countries are registered with the FDA to make Cradle, Patient, Radiologic (product code KXH, Class 1, 21 CFR 892.1830). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on November 16, 2012, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KXH
Device class
1
Regulation
892.1830
Medical specialty
Radiology

Makers by country

CountryMakers
United States9
Israel3
Canada2
China2
Japan1
Spain1
Switzerland1

Makers of Cradle, Patient, Radiologic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
GE Healthcare CoilsAurora, OH, United StatesSpecification developer1November 16, 2012000api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer1October 14, 1986000api.fda.gov
Alcare Co., Ltd Chiba Factory, EastChiba City, JapanManufacturer, Specification developer0000api.fda.gov
Armery Medical Technologies Inc.London Ontario, CanadaContract manufacturer, Specification developer0000api.fda.gov
Anatomical Geometry S.L.MAIRENA DEL ALJARAFE Sevilla, SpainForeign private label distributor, Manufacturer0000api.fda.gov
Creative Foam Corporation - BremenBremen, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer0000api.fda.gov
First Source Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Ge Medical Systems Israel, Functional ImagingTIRAT HACARMEL Haifa, IsraelManufacturer0000api.fda.gov
Ge Medical Systems Israel, Functional ImagingHaifa, IsraelSpecification developer0000api.fda.gov
GE Medical Systems Israel, Functional ImagingHaifa, IsraelManufacturer0000api.fda.gov
Guangdong Meicen Medical Equipment Co., Ltd.foshan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Tian Hong Medical Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hyperfine, IncGuilford, CT, United StatesManufacturer, Specification developer0000api.fda.gov
Octostop, Inc.LAVAL Quebec, CanadaManufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pearl Technology AGSchlieren Zurich, SwitzerlandComplaint file establishment, Manufacturer0000api.fda.gov
Reina ImagingCrystal Lake, IL, United StatesManufacturer0000api.fda.gov
THE INITIATIVE LLC., DBA KyphoLiftSouth Jordan, UT, United StatesSpecification developer0000api.fda.gov

Updated November 16, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.